Big Year for NMEs at FDA

In 2018, the FDA says it approved fifty-nine new molecular entities, which included a whopping thirteen biosimilar products.  All of the NME product approvals can be found here.

It is important for you the read the FDA explanation of how the Agency is defining NMEs for the purposes of this report and stay focused on the regulatory implications versus the practical implications of how the FDA is classifying this term.  Seventeen of the fifty-nine (28.8%) of the products approved were to treat some type of cancer.  There were also products to treat rare forms of epilepsy, travelers’ diarrhea, COPD, and infections, and to prevent migraines, to name a few.

All in all, a big year for the FDA in the NME arena!